Medicine Matters oncology

Hi. I'm Elizabeth Plimack. I direct GU medical oncology here at Fox Chase Cancer Center in Philadelphia in the United States. And it was my honor at this year's ASCO to discuss the JAVELIN 100 data as part of the Plenary session.

This trial is really impactful in the field of bladder cancer. It was a randomized trial taking patients who had responded to or achieved stable disease after platinum-based chemotherapy in the metastatic bladder cancer setting and randomized them to receive maintenance avelumab or best supportive care.

And the expectation was that after best supportive care, which would represent a treatment break, patients would then go on to get second-line therapy if their cancer progressed. And the results showed a clear benefit to avelumab in the switch-maintenance setting with a median overall survival of 21.4 months, which is meaningful in many ways. But right now, it's the longest overall survival we've ever seen in a phase III metastatic urothelial cancer trial, so certainly impressive.

Some of my comments on the abstracts were that these data are practice changing. I think they inform how we assess patients after platinum-based therapy in terms of going on to a treatment break versus initiating upfront checkpoint. I think these data, for most patients in most situations and most practice settings, favor starting a switch maintenance checkpoint right after a response or stable disease to platinum. And I think it also emphasizes that, really, to achieve these great results is probably best for all patients to start with platinum-based chemotherapy, rather than other options now, which include for some patients a checkpoint upfront. And this is because it seems that the best long term control is achieved by sequential chemotherapy followed by switch maintenance.

So lots of unanswered questions, lots of things we'd like to look at to further studies to understand. But I do think that JAVELIN 100 data sort of put a flag-- flag in the ground here for us in the urothelial community that this is a positive trial. It's a randomized trial. It was well designed. And it emphasizes a switch maintenance approach, which is-- will be new for us in bladder cancer treatment.

So some of the challenges in incorporating maintenance checkpoint therapy into the paradigm are ones that exist in terms of disparities in healthcare in practice settings. So for most practice settings, platinum is available. It's generic. It's been around for a long time.

But checkpoint inhibitors are expensive and not available in all countries. So for those patients, access will be an issue as it would be with any checkpoint inhibitor. I think I would urge treatment communities, payers, countries to approve checkpoint inhibition in this space based on the overall survival benefit. But I think that is one of the challenges.

The other challenge, when evaluating patient who really would like a treatment break, is to gauge their risk. So we did see from a separate study, an HCRN study, that overall survival could be the same if patients are guaranteed access to a checkpoint inhibitor after their treatment break. So there probably are patients who will do just fine waiting and not moving to switch maintenance right away. The challenge is we don't know who those patients are at the start. And we do know we will miss the opportunity to treat some patients if we wait. That being said, treatment breaks can be really important for patients. So this is something to be weighed on a patient-by-patient basis.